MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-07 for ROTATABLE OSTIUM PUNCH 8211.661 manufactured by Richard Wolf Gmbh.
[207727]
A metal fragment broke off of a rotatable ostium punch during sinus surgery. The piece was retrieved by the surgeon with no pt problems reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 338028 |
| MDR Report Key | 338028 |
| Date Received | 2001-06-07 |
| Date of Report | 2001-04-26 |
| Date of Event | 2001-03-15 |
| Date Facility Aware | 2001-03-15 |
| Report Date | 2001-04-26 |
| Date Reported to Mfgr | 2001-04-26 |
| Date Added to Maude | 2001-06-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTATABLE OSTIUM PUNCH |
| Generic Name | OSTIUM PUNCH |
| Product Code | KTF |
| Date Received | 2001-06-07 |
| Model Number | 8211.661 |
| Catalog Number | 8211.661 |
| Lot Number | P654487 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 23 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 327332 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | ROTATABLE OSTIUM PUNCH |
| Baseline Generic Name | OSTIUM PUNCH |
| Baseline Model No | 8211.661 |
| Baseline Catalog No | 8211.661 |
| Baseline ID | P660472 |
| Baseline Device Family | ENT SURGICAL INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-07 |